TAC01-HER2 is a novel therapy based on genetically engineered T-cells expressing a T-cell antigen coupler. Image credit: Kateryna Kon / Shutterstock.

GenFleet Therapeutics has dosed the first subject in a Phase Ib/II trial of GFH009 to treat relapsed/refractory peripheral T-cell lymphomas (PTCL).

The single-arm, open-label, multi-centre study will be carried out at approximately 40 hospitals in China, including the Sun Yat-Sen University Cancer Center and the First Affiliated Hospital of Zhengzhou University.

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It intends to enrol a total of 95 patients who will receive GFH009, a highly selective cyclin-dependent kinase9 (CDK9) inhibitor.

The company completed the dose escalation portion of its Phase I multi-centre trial of monotherapy for relapsed/refractory haematological malignancies in both the US and China.

Favourable safety/tolerability and clinical efficacy of GFH009 were demonstrated in preliminary studies, with complete or partial responses observed in lymphoma and acute myeloid leukaemia patients.

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Clinical response was observed in four PTCL patients, including one in continuous treatment for over 48 weeks.

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Based on the pharmacodynamics, pharmacokinetics, safety and efficacy data, the recommended Phase II dose has been determined as 100mg, which is to be taken once a week.

GenFleet Therapeutics chief medical officer Yu Wang said: “GFH009 is GenFleet’s first clinical-stage asset for haematological malignancies in a global multi-centre trial.

“Currently there is significant unmet medical need in recurrent/refractory PTCL; studies from GFH009 have confirmed its potential in combating the disease.

“Following on GFH009’s favourable safety profile and preliminary efficacy in the Phase I trial, we are planning to explore more studies of GFH009 monotherapy and combination therapies for global patients.”